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FDAFDA · Food and drugs·Recall number D-1357-2022

Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440

Published August 24, 2022 · Recall initiated: July 15, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Aire-Master of America Inc
Distributor
Florida, Illinois, Iowa, New Jersey
Lot
Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22
Risk classification
Class II
Area (FDA)
drug
Country
United States

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